Silex Medical recalls 20mm atraumatic grasper instruments with exposed shaft areas that could cause electrical shock during surgery.
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Silex Medical is recalling specific laparoscopic surgical instruments due to an exposed electrical area that could cause shock. This hazard affects instruments used in surgery, where electrical safety is critical.
The instrument's electrical insulation does not fully cover the shaft near the rotator wheel. This exposed area could cause electrical shock if the instrument comes into contact with bodily fluids or tissues during surgery.
Surgical teams using the recalled instruments during procedures. Patients and staff at medical facilities using these instruments are at risk of electrical shock.
Check for model number 5881033, UDI-DI B331:58810330, or lot number M28188. The instruments have a serial number starting with 0107 or 0108.
Verify the model number, UDI-DI, lot number, and serial numbers to confirm if your instrument is recalled.
The insulation on the tube does not extend fully to the proximal end of the shaft, leaving an exposed electrical area near the rotator wheel that could cause shock during surgery.
Look for model number 5881033, UDI-DI B33158810330, lot number M28188, or serial numbers starting with 0107 or 0108.
The recall record does not specify a remedy, so contact Silex Medical directly for guidance.
We’ve drafted a message you can send Silex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1900-2025 — Silex Medical Silex Medical Hello, I own a Silex Medical that is covered by recall Z-1900-2025 from Silex Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
